An endoscope is an instrument used to see inside a body lumen. A conventional medical endoscope includes a flexible tube, a functional control mechanism to direct the position of a distal end of the flexible tube, and a camera. The camera provides images of the internal body cavity to help the medical practitioner position the distal end of the flexible tube and confirm that the end is positioned at an acceptable location. When the endoscope is used in a medical procedure, the flexible tube of an endoscope is generally directed into an internal body cavity of a patient. During its use in the procedure by a medical practitioner, the endoscope may acquire high levels of microbial contamination. Such microbial contamination may include infectious agents or any number of harmful bacterial and viral microorganisms. In some cases, an endoscope used in a medical procedure on one patient is contaminated, improperly or insufficiently disinfected, and is then used in a medical procedure on another patient. In such cases, the health of the second patient is put at risk of microbial transmission or disease.
Medical practitioners work to prevent the spread of infection and disease by following strict procedures to clean and disinfect an endoscope. Unfortunately, most conventional endoscopes (e.g., bronchoscopes, colonoscopes, gastrointestinal endoscopes, nasopharyngoscopes, sigmoidoscopes, and the like) are heat sensitive and cannot be sterilized. Instead, the endoscopes are cleaned using alternative procedures, and are wiped, or even bathed, in high-level disinfectants.
When endoscopes are made of materials that can be sterilized, the hospital needs to set up a dedicated sterilization chamber and equip it with dedicated sterilization equipment and corresponding operators. The required sterilization procedure limits the frequency of reuse, and still carries the risk of cross infection etc. caused by imperfect sterilization.
In spite of rigid attempts to effectively clean endoscopes, some patients suffer injury, illness, and even death as a result of an endoscope that carries pathogens from one patient to another. In 2010, the ECRI Institute cited endoscopic contamination as one of the top 10 health risks in a document entitled “Top 10 Health Technology Hazards for 2011,” Reprinted from Volume 39, Issue 11, November 2012 by the ECRI Institute (www.ecri.org). A seminal work that studied and described the problem of improperly cleaned endoscopes is “Transmission of Infection by Gastrointestinal Endoscopy and Bronchoscopy,” from the Annals of Internal Medicine, 1993; 118:117-128 by the American College of Physicians.
Flexible endoscopes in general, and colonoscopes in particular, are difficult to clean and disinfect thoroughly, leading to potential problems of cross-contamination between patients, and between patients and staff. Additionally, such endoscopes often use costly devices such as camera heads, electro-mechanical steering devices, and control electronics modules, which cannot be readily sterilized, and because of their cost, cannot be discarded after every use.
The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors' offices) that utilize reusable medical devices are urged to review reprocessing practices at their facility to ensure they are complying with all steps as directed by the device manufacturers, and have in place appropriate policies and procedures that are consistent with standards and guidelines. Safety communications are published every year to guide hospitals and health care facilities that utilize colonoscopes to take additional steps to further reduce the risk of infection and increase the safety of these medical devices. They recognize that not all health care facilities can implement one or more of these measures, which require specific resources, training, and expertise. Reprocessing instructions are provided as a detailed, multistep process to clean and disinfect or sterilize reusable devices, and can result in infection transmission if reprocessing instructions are not followed in every step of the process.